TY - JOUR
T1 - Risk of carditis after three doses of vaccination with mRNA (BNT162b2) or inactivated (CoronaVac) covid-19 vaccination: a self-controlled cases series and a case–control study
AU - Fan, Min
AU - Lai, Francisco Tsz Tsun
AU - Cheng, Franco Wing Tak
AU - Tsie, Natalie Tsz Ying
AU - Li, Xue
AU - Wan, Eric Yuk Fai
AU - Wong, Carlos King Ho
AU - Chan, Esther Wai Yin
AU - Yiu, Kai Hang
AU - Wong, Ian Chi Kei
AU - Chui, Celine Sze Ling
N1 - Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
PY - 2023/6
Y1 - 2023/6
N2 - Background: Large-scale comparative research exploring the risk after the third dose and after inactivated covid-19 vaccination is limited. This study aimed to assess the risk of carditis following three doses of BNT162b2 or CoronaVac. Methods: We conducted a self-controlled case series (SCCS) and a case–control study using electronic health and vaccination records in Hong Kong. Carditis incidents within 28 days of covid-19 vaccination were included as cases. In the case–control study, up to 10 hospitalized controls were selected with stratified probability sampling by age, sex, and hospital admission (±1 day). The incidence rate ratios (IRRs) were reported from conditional Poisson regressions for SCCS, and adjusted odds ratios (ORs) were reported from multivariable logistic regressions. Findings: A total of 8,924,614 doses of BNT162b2 and 6,129,852 doses of CoronaVac were administered from February 2021 to March 2022. The SCCS detected increased carditis risks after BNT162b2: 4.48 (95%confidence interval [CI]:2.99–6.70] in 1–14 days and 2.50 (95%CI:1.43–4.38) in 15–28 days after first dose; 10.81 (95%CI:7.63–15.32) in 1–14 days and 2.95 (95%CI:1.82–4.78) in 15–28 days after second dose; 4.72 (95%CI:1.40–15.97) in 1–14 days after third dose. Consistent results were observed from the case–control study. Risks were specifically found in people aged below 30 years and males. No significant risk increase was observed after CoronaVac in all primary analyses. Interpretations: We detected increased carditis risks within 28 days after all three doses of BNT162b2 but the risk after the third doses were not higher than that of the second dose when compared with baseline period. Continuous monitoring of carditis after both mRNA and inactivated covid-19 vaccines is needed.
AB - Background: Large-scale comparative research exploring the risk after the third dose and after inactivated covid-19 vaccination is limited. This study aimed to assess the risk of carditis following three doses of BNT162b2 or CoronaVac. Methods: We conducted a self-controlled case series (SCCS) and a case–control study using electronic health and vaccination records in Hong Kong. Carditis incidents within 28 days of covid-19 vaccination were included as cases. In the case–control study, up to 10 hospitalized controls were selected with stratified probability sampling by age, sex, and hospital admission (±1 day). The incidence rate ratios (IRRs) were reported from conditional Poisson regressions for SCCS, and adjusted odds ratios (ORs) were reported from multivariable logistic regressions. Findings: A total of 8,924,614 doses of BNT162b2 and 6,129,852 doses of CoronaVac were administered from February 2021 to March 2022. The SCCS detected increased carditis risks after BNT162b2: 4.48 (95%confidence interval [CI]:2.99–6.70] in 1–14 days and 2.50 (95%CI:1.43–4.38) in 15–28 days after first dose; 10.81 (95%CI:7.63–15.32) in 1–14 days and 2.95 (95%CI:1.82–4.78) in 15–28 days after second dose; 4.72 (95%CI:1.40–15.97) in 1–14 days after third dose. Consistent results were observed from the case–control study. Risks were specifically found in people aged below 30 years and males. No significant risk increase was observed after CoronaVac in all primary analyses. Interpretations: We detected increased carditis risks within 28 days after all three doses of BNT162b2 but the risk after the third doses were not higher than that of the second dose when compared with baseline period. Continuous monitoring of carditis after both mRNA and inactivated covid-19 vaccines is needed.
KW - Adverse events of special interest
KW - Covid-19 vaccines
KW - Myocarditis
KW - Pericarditis
KW - Vaccine safety
UR - http://www.scopus.com/inward/record.url?scp=85151440005&partnerID=8YFLogxK
UR - https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(23)00063-9/fulltext
U2 - 10.1016/j.lanwpc.2023.100745
DO - 10.1016/j.lanwpc.2023.100745
M3 - Article
AN - SCOPUS:85151440005
SN - 2666-6065
VL - 35
JO - The Lancet Regional Health - Western Pacific
JF - The Lancet Regional Health - Western Pacific
M1 - 100745
ER -